AccessGUDID - DEVICE: ATLAS Stim Headbox Software (00850011306703)

GUDID

Device Identifier (DI) Information

Brand Name: ATLAS Stim Headbox Software
Version or Model: 1.5.1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 36-0301-0006
Company Name: NEURALYNX, INC.

Primary DI Number: 00850011306703
Issuing Agency: GS1
Commercial Distribution End Date: June 11, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 933200842 *Terms of Use

Device Description: Control software for the ATLAS Stim Headbox.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35726	Somatosensory electrical stimulation system	An assembly of devices used to apply precisely timed and repeatable electrical stimuli to the peripheral nerves, typically for evoked potential and other research procedures (e.g., functional mapping in epilepsy). It is usually a multichannel external stimulation system, consisting of external surface electrodes or invasive (i.e., needle) electrodes, and a pulse generator. It may be used as a component of more complex devices such as somatosensory evoked-potential recording systems.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GYC	Electrode, Cortical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K250094	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 57568104-9f7d-4de8-ba14-79017085b5fe
Public Version Date: June 19, 2025
Public Version Number: 1
DI Record Publish Date: June 11, 2025